Tendinopathy of Rotator CuffNCT07094178
Corticosteroid Versus PRP Injections for Shoulder Tendinopathy
A study testing Corticosteroid Injection and platelet-rich plasma injection in people with Tendinopathy of Rotator Cuff, run by Hopital Charles Nicolle at 1 site in Tunisia.
Trial summary
Shoulder tendinopathy is a common condition that causes shoulder pain and limits daily activities. It often results from damage or overuse of the rotator cuff tendons. Treatment typically includes rest, physical therapy, anti-inflammatory medications, and sometimes injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinopathy of Rotator Cuff
- What is being tested?
- Corticosteroid Injection and platelet-rich plasma injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 30 Jun 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Diagnosed with simple tendinopathy of the shoulder confirmed by clinical examination and imaging
- Experiencing shoulder pain for at least 4 weeks
- Able to provide informed consent
Who cannot join
- Previous shoulder surgery on the affected side
- Presence of rotator cuff tear or severe shoulder pathology
- Systemic inflammatory diseases (e.g., rheumatoid arthritis)
- Recent corticosteroid injection in the affected shoulder (within last 3 months)
- Contraindications to corticosteroids or PRP treatment
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Charles Nicolle Hospital
Tunis
Selma Bouden, Assistant doctor, 0021624685748, selma.bouden@gmail.com
About this study
Official title: Efficacy of Corticosteroid Versus Platelet-Rich Plasma Injections in the Treatment of Shoulder Tendinopathy: A Randomized Controlled Trial
Shoulder tendinopathy is a common condition that causes shoulder pain and limits daily activities. It often results from damage or overuse of the rotator cuff tendons. Treatment typically includes rest, physical therapy, anti-inflammatory medications, and sometimes injections.
This clinical trial aims to compare the effectiveness of two types of injections for treating simple shoulder tendinopathy:
Read more
Corticosteroid injections, which reduce inflammation and provide quick pain relief, but may have only short-term effects.
Platelet-Rich Plasma (PRP) injections, a newer treatment made from the patient's own blood, which may promote long-term healing.
The study is being conducted at the Rheumatology Department of Charles Nicolle Hospital in Tunis, Tunisia. A total of 60 adult patients with shoulder tendinopathy will be randomly assigned to receive either a corticosteroid injection or a PRP injection.
Participants will be evaluated before the injection (baseline), after one week, and after three months. The researchers will assess pain levels using a visual analog scale (VAS), and shoulder function using validated questionnaires (DASH and SPADI scores).
The goal is to determine which treatment provides better pain relief and functional improvement over time.
- Conditions
- Tendinopathy of Rotator Cuff
- Being tested
- Corticosteroid Injection, platelet-rich plasma injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid InjectionProcedure or surgery
This intervention consists of a single injection of corticosteroids administered directly into the affected tendon of the shoulder. Corticosteroids are anti-inflammatory drugs used to rapidly reduce inflammation and pain associated with tendinopathy. The injection is performed under aseptic conditions by a trained physician. The aim is to provide quick pain relief and improve shoulder function, although effects may be temporary.
platelet-rich plasma injectionProcedure or surgery
This intervention involves a single injection of Platelet-Rich Plasma (PRP), which is prepared from the patient's own blood through a process of centrifugation to concentrate platelets. PRP contains growth factors that may promote tissue healing and regeneration. The injection is administered under aseptic conditions into the affected shoulder tendon by a trained physician. The goal is to enhance long-term recovery of tendon function and reduce pain.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Injection | Experimental | Participants in this arm will receive a single infiltration of corticosteroids into the affected shoulder tendon. Corticosteroids are anti-inflammatory medications commonly used to reduce pain and inflammation in tendinopathies. The injection aims to provide rapid pain relief and improve shoulder function. Patients will be monitored for pain reduction and functional improvement at one week and three months after the injection. Receives: Procedure: Corticosteroid Injection |
| Platelet-Rich Plasma (PRP) Injection | Experimental | Participants in this arm will receive a single infiltration of Platelet-Rich Plasma (PRP) into the affected shoulder tendon. PRP is prepared from the patient's own blood and contains growth factors that may promote tissue healing and regeneration. This treatment aims to provide longer-term pain relief and functional improvement. Patients will be evaluated for pain and shoulder function at one week and three months following the injection. Receives: Procedure: platelet-rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores represent worse pain outcomes.
Measured: baseline, 1 week, 3 months
Change in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score
The DASH score ranges from 0 to 100. Higher scores indicate greater disability (worse function).
Measured: baseline, 1 week and 3 months
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
The SPADI score ranges from 0 to 100. Higher scores indicate greater pain and disability.
Measured: baseline, 1 week, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start30 Jun 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendinopathy of Rotator CuffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Charles Nicolle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Bouden, Hopital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094178
- Sponsor's protocol ID
- PRP-CS-2025-CN
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including clinical and demographic data) will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results. Requests can be submitted to the principal investigator, who will review and approve data sharing agreements to ensure participant privacy and compliance with ethical regulations.
Publications
Bouden S, Jebali C, Ben Dhia S, Rouached L, Saidane O, Mahmoud I, Tekaya R, Ben Tekaya A, Abdelmoula L. Shoulder injection of platelet-rich plasma versus corticosteroids in rotator cuff tendinopathies. Scand J Rheumatol. 2026 Mar 18:1-8. doi: 10.1080/03009742.2026.2620888. Online ahead of print.
PubMed 41848176
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Corticosteroid Versus Platelet-Rich Plasma Injections in the Treatment of Shoulder Tendinopathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07094178
- Acronym / sponsor ID
- PRP-CS-2025-CN
- Conditions
- Tendinopathy of Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hopital Charles NicolleUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder tendinopathy is a common condition that causes shoulder pain and limits daily activities. It often results from damage or overuse of the rotator cuff tendons. Treatment typically includes rest, physical therapy, anti-inflammatory medications, and sometimes injections.
This clinical trial aims to compare the effectiveness of two types of injections for treating simple shoulder tendinopathy:
Corticosteroid injections, which reduce inflammation and provide quick pain relief, but may have only short-term effects.
Platelet-Rich Plasma (PRP) injections, a newer treatment made from the patient's own blood, which may promote long-term healing.
The study is being conducted at the Rheumatology Department of Charles Nicolle Hospital in Tunis, Tunisia. A total of 60 adult patients with shoulder tendinopathy will be randomly assigned to receive either a corticosteroid injection or a PRP injection.
Participants will be evaluated before the injection (baseline), after one week, and after three months. The researchers will assess pain levels using a visual analog scale (VAS), and shoulder function using validated questionnaires (DASH and SPADI scores).
The goal is to determine which treatment provides better pain relief and functional improvement over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injection | Experimental | Procedure: Corticosteroid InjectionParticipants in this arm will receive a single infiltration of corticosteroids into the affected shoulder tendon. Corticosteroids are anti-inflammatory medications commonly used to reduce pain and inflammation in tendinopathies. The injection aims to provide rapid pain relief and improve shoulder function. Patients will be monitored for pain reduction and functional improvement at one week and three months after the injection. |
| Platelet-Rich Plasma (PRP) Injection | Experimental | Procedure: platelet-rich plasma injectionParticipants in this arm will receive a single infiltration of Platelet-Rich Plasma (PRP) into the affected shoulder tendon. PRP is prepared from the patient's own blood and contains growth factors that may promote tissue healing and regeneration. This treatment aims to provide longer-term pain relief and functional improvement. Patients will be evaluated for pain and shoulder function at one week and three months following the injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Diagnosed with simple tendinopathy of the shoulder confirmed by clinical examination and imaging
- Experiencing shoulder pain for at least 4 weeks
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Previous shoulder surgery on the affected side
- Presence of rotator cuff tear or severe shoulder pathology
- Systemic inflammatory diseases (e.g., rheumatoid arthritis)
- Recent corticosteroid injection in the affected shoulder (within last 3 months)
- Contraindications to corticosteroids or PRP treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid InjectionThis intervention consists of a single injection of corticosteroids administered directly into the affected tendon of the shoulder. Corticosteroids are anti-inflammatory drugs used to rapidly reduce inflammation and pain associated with tendinopathy. The injection is performed under aseptic conditions by a trained physician. The aim is to provide quick pain relief and improve shoulder function, although effects may be temporary. | Procedure or surgery | Corticosteroid Injection |
| platelet-rich plasma injectionThis intervention involves a single injection of Platelet-Rich Plasma (PRP), which is prepared from the patient's own blood through a process of centrifugation to concentrate platelets. PRP contains growth factors that may promote tissue healing and regeneration. The injection is administered under aseptic conditions into the affected shoulder tendon by a trained physician. The goal is to enhance long-term recovery of tendon function and reduce pain. | Procedure or surgery | Platelet-Rich Plasma (PRP) Injection |
Primary outcome
Change in pain intensity measured by Visual Analog Scale (VAS)
Time frame: baseline, 1 week, 3 months
The Visual Analog Scale (VAS) ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores represent worse pain outcomes.
Change in shoulder function measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: baseline, 1 week and 3 months
The DASH score ranges from 0 to 100. Higher scores indicate greater disability (worse function).
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
Time frame: baseline, 1 week, 3 months
The SPADI score ranges from 0 to 100. Higher scores indicate greater pain and disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 41848176Bouden S, Jebali C, Ben Dhia S, Rouached L, Saidane O, Mahmoud I, Tekaya R, Ben Tekaya A, Abdelmoula L. Shoulder injection of platelet-rich plasma versus corticosteroids in rotator cuff tendinopathies. Scand J Rheumatol. 2026 Mar 18:1-8. doi: 10.1080/03009742.2026.2620888. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including clinical and demographic data) will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results. Requests can be submitted to the principal investigator, who will review and approve data sharing agreements to ensure participant privacy and compliance with ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid Injection and platelet-rich plasma injection in people with Tendinopathy of Rotator Cuff, run by Hopital Charles Nicolle at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selma Bouden, Assistant doctor (0021624685748, selma.bouden@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Visual Analog Scale (VAS) (time frame: baseline, 1 week, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07094178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.